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1. Accessibility and potency of uterotonic drugs purchased by simulated clients in four districts in India

Author

Alissa Koski, Cynthia Stanton, Deepak Nitya Nand, Breanne Grady, Ellie Mirzabagi, Luke C. Mullany, and Steve Brooke

Subjects
Drug, medicine.medical_specialty, Methylergometrine, media_common.quotation_subject, Psychological intervention, India, Uterotonics, Pharmacy, Uterotonic, Oxytocin, Toxicology, Methylergonovine, Pregnancy, Oxytocics, Obstetrics and Gynaecology, Medicine, Potency, Humans, Agra, Misoprostol, media_common, Gynecology, Pharmacies, biology, business.industry, Postpartum Hemorrhage, Obstetrics and Gynecology, biology.organism_classification, Quaternary Ammonium Compounds, Medicines quality, Female, Private Sector, business, medicine.drug, Research Article
Abstract

Background Surveillance of drug quality for antibiotics, antiretrovirals, antimalarials and vaccines is better established than surveillance for maternal health drugs in low-income countries, particularly uterotonic drugs for the prevention and treatment of postpartum hemorrhage. The objectives of this study are to: assess private sector accessibility of four drugs used for uterotonic purposes (oxytocin, methylergometrine, misoprostol, valethamate bromide); and to assess potency of oxytocin and methylergometrine ampoules purchased by simulated clients. Methods The study was conducted in Hassan and Bagalkot districts in Karnataka state and Agra and Gorakhpur districts in Uttar Pradesh state. A sample of 877 private pharmacies was selected (using a stratified, systematic sampling with random start), among which 847 were successfully visited. The target sample size for assessment of accessibility was 50 pharmacies per drug, per district. The target sample size for potency assessment was 100 purchases each of oxytocin and methylergometrine across all districts. Successful drug purchases varied by state. Results In Agra and Gorakhpur, 90%-100% of visits for each of the drugs resulted in a purchase. In Bagalkot and Hassan, only 29%-52% of visits for each drug resulted in a purchase. Regarding potency, the percent of active pharmaceutical ingredient was assessed using United States Pharmacopeia monograph #33 for both drugs; 193 and 188 ampoules of oxytocin and methylergometrine, respectively, were assessed. The percent of oxytocin ampoules outside manufacturer specification ranged from 33%-40% in Karnataka and from 22%-50% in Uttar Pradesh. In Bagalkot and Hassan, 96% and 100% of the methylergometrine ampoules were outside manufacturer specification, respectively. In Agra and Gorakhpur, 54% and 44% were outside manufacturer specification, respectively. Conclusion Private sector accessibility of uterotonic drugs in study districts in Karnataka warrants attention. Most importantly, interventions to assure quality oxytocin and particularly methylergometrine are needed in study districts in both states.

Published
2014

2. Knowledge, Attitudes, and Practices Related to Uterotonic Drugs during Childbirth in Karnataka, India: A Qualitative Research Study.

Author

Deepak, Nitya Nand, Mirzabagi, Ellie, Koski, Alissa, and Tripathi, Vandana

Subjects
*ATTITUDE (Psychology), *PUBLIC health, *MATERNAL mortality, *CHILDBIRTH, *HEALTH policy, *ETIOLOGY of diseases, *GYNECOLOGY, *OBSTETRICS, *EMERGENCY medicine, *QUALITATIVE research
Abstract

Background and Objectives: India has the highest annual number of maternal deaths of any country. As obstetric hemorrhage is the leading cause of maternal death in India, numerous efforts are under way to promote access to skilled attendance at birth and emergency obstetric care. Current initiatives also seek to increase access to active management of the third stage of labor for postpartum hemorrhage prevention, particularly through administration of an uterotonic after delivery. However, prior research suggests widespread inappropriate use of uterotonics at facilities and in communities–for example, without adequate monitoring or referral support for complications. This qualitative study aimed to document health providers’ and community members’ current knowledge, attitudes, and practices regarding uterotonic use during labor and delivery in India’s Karnataka state. Methods: 140 in-depth interviews were conducted from June to August 2011 in Bagalkot and Hassan districts with physicians, nurses, recently delivered women, mothers-in-law, traditional birth attendants (dais), unlicensed village doctors, and chemists (pharmacists). Results: Many respondents reported use of uterotonics, particularly oxytocin, for labor augmentation in both facility-based and home-based deliveries. The study also identified contextual factors that promote inappropriate uterotonic use, including high value placed on pain during labor; perceived pressure to provide or receive uterotonics early in labor and delivery, perhaps leading to administration of uterotonics despite awareness of risks; and lack of consistent and correct knowledge regarding safe storage, dosing, and administration of oxytocin. Conclusions: These findings have significant implications for public health programs in a context of widespread and potentially increasing availability of uterotonics. Among other responses, efforts are needed to improve communication between community members and providers regarding uterotonic use during labor and delivery and to target training and other interventions to address identified gaps in knowledge and ensure that providers and pharmacists have up-to-date information regarding proper usage of uterotonic drugs. [ABSTRACT FROM AUTHOR]

Published
2013
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